DIFLUCAN Hard capsule (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Diflucan 150 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains fluconazole 150 mg Excipient(s) with known effects: each hard capsule also contains 149.12 mg lactose monohydrate For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. The 150 mg hard gelatin capsule has a turquoise blue body and turquoise blue cap overprinted with Pfizer and the code FLU-150 with black ink. The capsule size is no. 1.
Therapeutic indications
Diflucan is indicated in the following fungal infections (see section 5.1). Diflucan is indicated in adults for the treatment of: Cryptococcal meningitis (see section 4.4). Coccidioidomycosis (see section ...
Posology and method of administration
Posology The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests ...
Contraindications
Hypersensitivity to the active substance, to related azole substances, or to any of the excipients listed in section 6.1. Coadministration of terfenadine is contraindicated in patients receiving Diflucan ...
Special warnings and precautions for use
Tinea capitis Fluconazole has been studied for treatment of tinea capitis in children. It was shown not to be superior to griseofulvin and the overall success rate was less than 20%. Therefore, Diflucan ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of the following other medicinal products is contraindicated Cisapride There have been reports of cardiac events including torsades de pointes in patients to whom fluconazole and cisapride ...
Fertility, pregnancy and lactation
Pregnancy An observational study has suggested an increased risk of spontaneous abortion in women treated with fluconazole during the first trimester. There have been reports of multiple congenital abnormalities ...
Effects on ability to drive and use machines
No studies have been performed on the effects of Diflucan on the ability to drive or use machines. Patients should be warned about the potential for dizziness or seizures (see section 4.8) while taking ...
Undesirable effects
The most frequently (>1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline ...
Overdose
There have been reports of overdose with Diflucan. Hallucination and paranoid behaviour have been concomitantly reported. In the event of overdose, symptomatic treatment (with supportive measures and gastric ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives ATC code: J02AC01 Mechanism of action Fluconazole is a triazole antifungal agent. Its primary mode of action is the inhibition ...
Pharmacokinetic properties
The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral route. Absorption After oral administration fluconazole is well absorbed, and plasma levels ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the human exposure indicating little relevance to clinical use. Carcinogenesis Fluconazole showed no ...
List of excipients
Capsule content: Lactose monohydrate Maize starch Colloidal silica anhydrous Magnesium stearate Sodium laurilsulfate Capsule shell composition: 150 mg capsules: Gelatin (E441) Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
150 mg capsules: clear PVC blister packs or white opaque PVC/PVDC blister packs with aluminium foil backing. Each pack contains 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 or 500 hard capsules. ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0290
Date of first authorization / renewal of the authorization
Date of first authorisation: 07 June 1988 Date of latest renewal: 02 December 2008
Date of revision of the text
03/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
